Kornimate/medical-research-clean huggingface dataset:
prospective, open-label, single-center, non-comparative study to assess the use of pixel co2 laser system (femilift) in the treatment of vulvovaginal atrophy (vva) in postmenopausal female subjects

Conditions: Atrophy; Vaginal Atrophy; Genital Diseases, Female

Summary: the purpose of this study is to assess the use of the alma co2 pixel femilift™ in the treatment of vulvovaginal atrophy (vva) in postmenopausal female subjects. the primary endpoint is to assess the change in the vaginal dryness by means of a visual analogic scale (10 cm vas) and/or bachmann index in vva. the clinical improvement will be assessed by patient filled vulvovaginal atrophy.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking * woman, age 35 to 70 yrs, menopausal * provided written informed consent * exhibiting vva and/or sui symptoms (mild or moderate sui, according to severity index developed by sandvik.) * prolapse staged \< ii, according to the pelvic organ prolapse quantification (ics-pop-q) system * normal pap smear (up to 1 year prior to baseline) * vaginal canal, introitus and vestibule free of injuries and bleeding * have not had procedures in the anatomical area through 6 months prior to treatment * understand and accept the obligation and is logistically able to present for all scheduled follow-up visits exclusion criteria: * severe prolapse (pop\>= grade 3) * use of photosensitive drugs * acute or recurrent urinary tract infection (uti), or genital infection (e.g. herpes candida). * any serious disease, or chronic condition, that could interfere with the study compliance * acute or actively present within the last 2 months hpv/hsv * undiagnosed vaginal bleeding * urge or overflow incontinence * patients who are on antidepressants, or α-adrenergic and anticholinergic medications * patients with immune system diseases. * patients with allergic reaction to laser. * obese women (bmi \>30) * patient unable to follow post-treatment instructions * history of keloid formation * received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin e or anti inflammatories within 2 weeks pre treatment * a history of thrombophlebitis * a history of acute infections * a history of heart failure * previously undergone reconstructive pelvic surgery * have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months * any medical condition that in the investigators opinion would interfere with the patients participation in the study
understanding patient perspectives on the risks of ionizing radiation used for medical imaging

Conditions: Breast Cancer; Colon Cancer; Lung Cancer; Neuroblastoma; Testicular Cancer

Summary: risks from imaging-related radiation exposure have become a popular topic in the media. because these tests are commonly applied to patients at a cancer center, it is important to understand what patients know, how they feel about what they know, where they get their information, and how satisfied they are with available risk-benefit communication on this topic. the purpose of this study is to understand how cancer patients perceive risks and benefits of diagnostic radiation and their satisfaction with healthcare communication on this topic.


Eligibility criteria:
inclusion criteria: * english-language fluent * 18 years of age, or older * provide informed consent * group 1: patients undergoing chemotherapy for stage iv colorectal carcinoma. * group 2: parents of pediatric patients who have undergone treatment for stage 1-3 neuroblastoma. * group 3: women who have undergone treatment for early stage breast cancer within the preceding 6 months. * group 4: men undergoing surveillance imaging after treatment for testicular cancer. * group 5: patients currently or previously enrolled in the mskcc lung cancer screening program. * group 6: patients enrolled in or eligible for the thoracic survivorship program. exclusion criteria: * participants who don't speak english

Keywords: quality of life focus groups risks of ionizing radiation risk of medical imaging 11-185
duragesic® (fentanyl transdermal system) functionality trial in chronic low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to assess physical functionality changes over a minimum of 9 weeks in patients with non-malignant chronic low back pain who are taking short-acting opioids (narcotic pain medications) for 4 or more weeks, and who start taking the long-acting opioid fentanyl in the form of a transdermal (skin) patch.

chronic pain (pain that lasts for more than 3 months) can limit physical functioning and negatively affect a person socially and emotionally. chronic low back pain (that is not caused by cancer) is a very common condition that affects up to a third of people in the us at any time. the primary objective of the trial is to assess functionality changes over a minimum period of 9 weeks using the oswestry disability index (odi) - a questionnaire to measure disability - in patients with non-malignant chronic low back pain who are taking short-acting opioids chronically, and who initiate treatment with duragesic® (transdermal fentanyl). the patch delivers fentanyl in doses of 25, 50, 75, or 100 micrograms per hour. the odi is comprised of 10 sections; each section consists of 6 response alternatives. the 10 scales assessed by the odi are pain intensity, personal care (washing, dressing, etc.), lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. the secondary objective is to assess changes in health-related quality of life (hrqol) over the treatment period using the total pain experience (tpe) subscale of the treatment outcomes in pain survey (tops), a questionnaire designed to measure hrqol changes in patients with chronic pain. the tops contains 112 items that are scored into 16 scales. these scales include: pain symptoms, lower body functional limitations, upper body functional limitations, perceived family/social disability, objective family/social disability, objective work disability, tpe (a combination of 5 other scales), life control, passive coping, solicitous responses, work limitations, fear avoidance, patient satisfaction with outcomes, health care satisfaction, vitality, and mental health (the last two from a questionnaire known as the short form-36, or sf-36. fentanyl transdermal system (skin patch) in a dosage prescribed by the clinical investigator according to the usual standard of care.

Eligibility criteria:
inclusion criteria: * chronic low back pain (not related to cancer) for at least 3 months * current use of short-acting opioid (narcotic pain medication) for at least 4 weeks * initiating fentanyl transdermal patch. exclusion criteria: * confusion or reduced level of consciousness * skin disease * malignancies (cancer) * currently hospitalized * treated with a long-acting opioid within the last 2 months * pregnant or breast-feeding * abusing drugs or alcohol

Keywords: chronic low back pain opioid fentanyl
intraoperative imaging of breast cancer with indocyanine green

Conditions: Invasive Ductal Carcinoma; Invasive Lobular Carcinoma; Ductal Carcinoma

Summary: according to the world health organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. the who also posit that nearly 420,000 women perished from the disease in 2002. surgery remains the best option for patients presenting with operable stage i, ii or iii cancers. breast conservation surgery has been shown to be as efficacious as mastectomy. about 60-70% of these women with operable breast cancer are breast conservation candidates. however, the need to achieve negative tumor margins often requires a second operation (re-excision) in up to 70% of the women having lumpectomy surgery. currently, tumor margins assessment in the operating room is often assessed grossly by palpation. the ability to evaluate tumor margin using our proposed intraoperative imaging technique may provide the surgeon with an alternative, and hopefully, more sensitive method to assess tumor margins which may decrease re-excision and the morbidity associated with additional surgery, and, perhaps, lower the risk of local regional recurrence.


Eligibility criteria:
inclusion criteria: 1. adult patients over 18 years of age 2. women with newly diagnosed, operable invasive ductal carcinoma, invasive lobular carcinoma or ductal carcinoma who are deemed breast conservation surgery candidates (i.e. lumpectomy +/- sentinel node biopsy). 3. breast cancer needs to be unifocal as determined by clinical parameters, e.g. by palpation or by breast imaging findings including mammogram, us and/or breast mri. multifocal disease, i.e. cancer confined to one quadrant, is eligible if patients are deemed breast conservation candidates. 4. subject capable of giving informed consent and participating in the process of consent. exclusion criteria: 1. newly diagnosed breast cancer patients who are not breast conservation candidates and those with multicentric breast cancer (breast cancer documented in multiple quadrants by breast imaging or exam) 2. pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hcg) within 72 hours of surgery 3. subjects with a history of iodide allergies 4. at-risk patient populations 1. homeless patients 2. patients with drug or alcohol dependence 3. patients unable to participate in the consent process
effectiveness of srp+ lipo-curcumin gel for the treatment of stage iii periodontitis.

Conditions: Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss

Summary: the aim of the present study is to clinically and radiographically compare the effectivness of scaling and root plannig (srp) in association with lipo-curcumin gel (lc) respect srp+ lipo-gel (l), srp+ discharged (d) gel and srp alone. this study will be designed as a randomized clinical trial of 12-month duration. a total of 40 patients will be recruited and randomly equally distributed into 4 groups: an experimental group treated with srp + lc, a first control group treated with srp + l, a second control group treated with srp+d and a third control group srp alone. each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. caution will be taken to preserve the stability of soft tissues. following srp, experimental and control sites will be randomly chosen. the test sites will be t filled with a lipo-curcumin gel and sealed with cyanoacrylate. in the first control group the defects will be be filled with a lipo gel and sealed with cyanoacrylate. in the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate, in the third control group srp alone will be performed. pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (hufriedy unc 15). before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of periodontitis stage iii (grades a to c) * on-smokers or former smokers who quit at least 1 year ago, and had not received any periodontal treatment in the 3 months prior to recruitment * fmps \< 20% at baseline * furcation not involved * not pregnant or lactating * signed informed consent exclusion criteria: * presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an hba1c\>7%, rheumatoid arthritis or any form of immunosuppression * patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment * chronic intake of nsaids or steroids, currently

Keywords: curcumin srp liposome periodontitis
efficacy and safety study of atorvastatin versus simvastatin in type 2 diabetic subjects with hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to evaluate the efficacy of atorvastin vs simvastatin in decreasing ldl-c in diabetic subjects with hypercholesterolemia at the end of the treatment phase.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * ldl-c \> 130 mg/dl exclusion criteria: * insulin therapy * clinically relevant organ disease (creatininemia \>2mg/dl, chf nyha iii and iv)
gene expression profiles in patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study uses gene expression profiling to compare primary tumor cells with metastatic tumor cells in patients with metastatic pancreatic cancer.

objectives: * compare the gene expression profiles of pancreatic cancer cells from the primary and metastatic sites in patients with metastatic pancreatic cancer. * characterize the function of the differentially upregulated and downregulated genes identified by comparing the gene expression profiles of primary and metastatic cells in these patients. outline: fresh biopsy samples are collected for gene expression profiling and other biomarker/laboratory analyses. projected accrual: a total of 10 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of pancreatic adenocarcinoma of exocrine origin * metastatic disease * fresh biopsy material available from primary site of disease and a metastatic focus, including liver, peritoneum, or lymph node patient characteristics: * not specified prior concurrent therapy: * no prior chemotherapy or radiotherapy for pancreatic cancer

Keywords: recurrent pancreatic cancer stage iv pancreatic cancer
a study to assess bms-986460 in participants with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the purpose of this study is to assess the safety, tolerability, and preliminary efficacy of bms-986460 in men with metastatic castration-resistant prostate cancer.


Eligibility criteria:
inclusion criteria: * participant must have histologically or cytologically confirmed adenocarcinoma of the prostate. * participant must have an eastern cooperative oncology group (ecog) performance status 0 to 1. * participant must have prostate specific antigen (psa) of ≥ 2 ng/ml at screening * participant must have progressed on androgen deprivation therapy (adt) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (crpc) exclusion criteria: * participant must not have history of brain metastases. * participant must not have impaired cardiac function or clinically significant cardiac disease. * participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on investigator assessment. other protocol-defined inclusion/exclusion criteria apply

Keywords: prostate cancer castration-resistant prostate cancer adenocarcinoma of the prostate prostatic neoplasms castration-resistant neoplasms
evaluation of thioldisulfide balance in cervical preinvasive lesions

Conditions: Oxidative Stress; Low Grade Squamous Intraepithelial Lesion; High-Grade Squamous Intraepithelial Lesions

Summary: the purpose of this study is to investigate thiol-disulfide balance in patients with cervical preinvasive lesions

to date various oxidative stress paramaters were studied in patients with cervical preinvasive lesions, however dynamic thiol disulfide hemostasis has not been previously investigated. the thiol-disulfide balance in the circulation will be measured by the automated system created by erel \& neselioglu(1). references 1- erel o, neselioglu s. a novel and automated assay for thiol/ disulphide homeostasis. clin biochem 2014;47:326-32. doi:10.1016/ j.clinbiochem.2014.09.026.

Eligibility criteria:
inclusion criteria: • histopathologically confirmed diagnosis of lgsil or hgsil exclusion criteria: * pulmonary disease * pulmonary hypertension * cardiac dysfunction * renal dysfunction * liver disease * chronic ishemia * systemic inflammation * other cervical biopy results than lgsil or hgsil * concomitant malignancy * patients who use vitamin a,c or e (antioxidant vitamins) * patients who use smoke • patients who use drink alcohol * patients who use addictive for any drug

Keywords: thiol disulfide balance preinvasive lesion cervix oxidative stress
genomic and proteomic analysis of disease progression in idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of the study is to identify genetic and biologic markers that may predict the loss of lung function due to idiopathic pulmonary fibrosis. the studies will compare genetic and biologic markers of samples to changes in symptoms. the ultimate goal is to predict if or when patients are likely to experience a rapid decline in lung function due to disease progression.

people who are diagnosed with idiopathic pulmonary fibrosis are asked to participate in this study. the subject must be treated at the dorothy p. and richard p. simmons center for interstitial lung disease. subjects, if consented, are required to perform tests so that research data can be collected. at the initial visit, patients are subject to having a blood draw, pulmonary function testing, echocardiograms, and ct scans as well as completing several questionnaires designed to measure how the patient is feeling. follow up visits are then scheduled in 3-4 month intervals. every 3-4 months blood samples will be collected while every 6-8 months the questionnaires will administered. if the patient enters a stage of accelerated decline in lung function, a bronchoscopy will be performed to collect residual bronchoalveolar lavage fluid for testing. all of the results of clinical and laboratory testing will be placed into the subjects research file.

Eligibility criteria:
inclusion criteria: * patients who are 18 or older * diagnosis of idiopathic pulmonary fibrosis * treated at the simmons center exclusion criteria: * other lung illness

Keywords: lung fibrosis idiopathic biomarkers genomics longitudinal
wound contamination during orthopaedic surgery

Conditions: Surgical Site Infection; Hip Fractures; Orthopedic Disorder; Implant Infection

Summary: in the present study we will compare bacteriological findings and the incidence of ssi in relation to laminar airflow (laf) ventilated ors, conventional (also called displacement or mixed) ventilated ors and conventional ventilated ors with the addition of tables equipped with units providing a local laf over the surgical instruments. the hypothesis is that there exist a correlation between number and types of airborne bacteria and bacteria in the surgical wound and on surgical instruments at the time of wound closure.

the scientific literature on the relationship between airborne bacteria and wound contamination during different conditions is scares. a study from 1982 (whyet et al.), demonstrated that the most important and consistent source of contamination of the wound during clean surgery (in this case hip implant surgery) was via air. the study concluded that approximately one third of bacteria in the wound were caused by direct air contamination whereas the remaining number of bacteria were transferred to the wound by indirect routes such as via contaminated instruments. the present study includes patients undergoing hemiarthroplastic surgery due to hip fracture. during the surgery active air sampling, for microbial analysis, will be done within 30 cm from the wound. passive sampling of instrument tables, to measure number of depositing bacteria on the surface during the procedure, will be performed by placing sterile filters on the table surfaces before initiating the surgical procedure and collecting them at the end. skin and wound sampling will be performed with sterile flocked nylon swabs. the method for skin and wound sampling was decided based on a literature review and discussions with the department of clinical microbiology at sahlgrenska university hospital. both aerobe and anaerobe bacteria will be analyzed. the wound will be measured and number of personnel, door openings and clothing, at each procedure will be recorded. patients included in the study will be interviewed after 6 weeks and 1 year, to evaluate incidence rate of ssi.

Eligibility criteria:
inclusion criteria: * patients undergoing hip fracture surgery treated with hemiarthroplasty implant and that are subsequently cared for at participating ortho-geriatric unit exclusion criteria: * patients that will not give their informed consent. * patient that, at the time of surgery, have an infection in any part of the body, hospital or community acquired. * patients receiving fracture fixation with pins only

Keywords: laf udf ssi wound contamination infection control airborne contamination operating room